EMA reports on international API inspection programme, 2017–2024

by

EMA’s report reviews the International API Inspection Programme from 2017 to 2024. Across 13 participating authorities, information was shared on 936 inspected sites and 1,684 inspections, approximately 50% more inspections than in the previous period. Of the sites, 644 (69%) were of shared interest; inspection reliance was reported for 107 sites. Authorities conducted 91 remote inspections, while 27 joint inspections covered 25 sites. Duplicate inspections affected 32% of sites and were more frequent following non-compliant outcomes. The report identifies legal, confidentiality, language, technical and resource barriers to report sharing and centralised data exchange. It recommends timelier information sharing, improved report usability, stronger reliance practices and action on duplication.

Centric Compounding Recalls Six Injectable Lots for Elevated Endotoxin

by

Centric Compounding voluntarily recalled six lots of compounded Glutathione 200 mg/mL, Myer’s Cocktail, and Tri-Immune Boost injectable products to the consumer level after finding that they were compounded with Glutathione API containing elevated endotoxin levels. The affected products are 30 mL multidose vials distributed nationwide to patients and prescribers. The company reported nine accounts of symptoms including fever, chills, chest pain, nausea/vomiting, headache, and/or malaise. It warned that injectable products with elevated endotoxin could cause serious events, including hypotension, inflammatory reactions, anaphylactic shock, and death. Customers are being notified, replacements arranged, and consumers instructed to stop using and discard affected vials.

FDA Compounding Policy and Rule Resources Updated Through September 2026

by

The FDA page compiles policy documents and related materials governing human drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. Its latest listed item is final guidance dated September 4, 2026 on temporary policies for compounding certain starter parenteral nutrition drug products for neonates. It also lists an April 30, 2026 Federal Register notice on the section 503B clinical-need list for bulk drug substances, with an FDA statement proposing exclusion of semaglutide, tirzepatide, and liraglutide. Earlier entries cover bulk substances, temporary parenteral compounding policies, outsourcing facilities, insanitary conditions, current good manufacturing practice, reporting, distribution, and repackaging. The page identifies its content as current as of September 9, 2026.

FDA Warning Letter: Happy Farm Botanicals cited for component testing, stability, and validation failures

by

FDA states that its March 30 to April 2, 2026, inspection of Happy Farm Botanicals’ OTC drug facility found significant CGMP violations. The firm did not perform specific identity testing on incoming raw materials and components, including APIs, before use; one API lot received only organoleptic testing and was used in finished batches. FDA also found a lapsed supplier requalification and no adequate validation of supplier test analyses. The stability program lacked adequate chemical and microbiological support for labeled expiry periods: accelerated studies lacked controlled humidity records, several timepoints were unavailable, and failing viscosity results in accelerated and long-term studies were not investigated. FDA’s quality unit findings included absent process validation for OTC products, absent cleaning validation for non-dedicated equipment, inadequate investigation and CAPA for recurring gasket seal failures, and inappropriate API content release limits. FDA deemed the firm’s response inadequate and noted that process and cleaning validation commitments from the 2024 inspection remained incomplete. The firm reported plans to cease production of the specified drugs at this facility.

Revised procedure for coordinating GMP inspections of centrally authorised products

by

Version 3 of the guideline, adopted in April 2026 and entering into force on 10 September 2026, describes EMA coordination of GMP inspections conducted by EEA competent authorities for centrally authorised products. It covers pre-approval inspections, for-cause inspections and routine risk-based re-inspections, including inspection triggers, authority selection, preparation, site contacts and report submission through IRIS. The revision clarifies that, where a Supporting Authority is unnecessary, one Authority may perform both leading and supporting roles. Applicants should identify proposed manufacturing, testing and batch-release sites before submission, and all listed sites should be inspection-ready and compliant with EU or equivalent GMP from submission.

FDA Warning Letter: Jabil sterile manufacturing deficiencies involving fungal contamination and quality oversight

by

FDA’s February 23 to March 6, 2026, inspection of Pharmaceutics International, Inc., a Jabil company and contract manufacturer of sterile injectables, identified significant finished-pharmaceutical CGMP violations. FDA found inadequate investigations of a sterility failure involving Ustilago spermophora and recurring fungal recoveries in Grade A filling areas, including insufficient root-cause analysis, trend evaluation, and CAPA. The quality unit did not ensure complete documentation of aseptic interventions; one batch record documented 12 interventions although records indicated approximately 200 occurred. FDA also cited inadequate disinfectant efficacy studies and failure to perform process validation after adding a production step. Airflow visualization studies were deficient or omitted following RABS modifications, and some interventions lacked adequate smoke visualization. Environmental monitoring used insufficient sampling techniques and locations. Classified areas also had peeling paint and plastic debris. FDA considered the company’s responses inadequate because they did not sufficiently address contamination sources, systemic investigation weaknesses, quality oversight, or sustainable remediation.

FDA Warning Letter: Unapproved Injectable Peptide Drugs Marketed by Royal Peptides

by

FDA identified violations during a July 2026 review of Royal Peptides LLC’s website. FDA determined that products marketed as Tirzepatide, Semaglutide, Retatrutide, SS-31 (Elamipretide), PT-141, Tesamorelin, and BIMORELIN were drugs based on claims concerning metabolic regulation, weight loss, mitochondrial function, hormone modulation, recovery, and sexual dysfunction. FDA stated that these products were unapproved new drugs because they were not generally recognized as safe and effective for the labeled uses and had no approved applications in effect. Although product labeling included statements such as “for research use only” and “not for human or animal consumption,” FDA cited website evidence indicating intended human drug use. FDA also noted that the firm marketed bacteriostatic water with a peptide guide and calculator that collectively provided means to prepare an injectable drug for human administration. The letter does not describe a manufacturing-site inspection or identify specific CGMP, laboratory, validation, facility, or quality-system deficiencies.

FDA Warning Letter: Reliance Life Sciences cited for data integrity and aseptic processing deficiencies

by

FDA’s February 19–27, 2026 inspection of Reliance Life Sciences’ Navi Mumbai drug facility identified significant CGMP violations involving laboratory data, sterile manufacturing, and quality oversight. FDA found environmental monitoring and other microbiology samples recorded as collected and incubated even though plates were absent and analysts confirmed the samples were not collected. LIMS calculations omitted required dilution factors, while electronic integrity-testing files lacked unique names and were overwritten; testing was also not performed for one plant. FDA said these deficiencies created a risk of underreported microbial findings and unreliable batch-release evidence. In aseptic operations, investigators observed operators blocking unidirectional airflow over critical locations and not discarding potentially compromised vials. FDA also observed deteriorated or damaged manufacturing areas or components, excess sealant near HEPA filters, nonsterile wipes used for cleaning, and standing water and staining near pipelines. FDA deemed the firm’s responses insufficient, citing incomplete remediation detail, traceability, oversight, and timelines. The company agreed to recall all sterile drugs and suspend U.S.-market production; FDA later placed its drugs on Import Alert 66-40.

FDA Warning Letter: PReye cited for unsuitable aseptic processing and inadequate quality systems

by

FDA states that its March 17–19, 2026, inspection of PReye’s drug manufacturing facility found significant finished-pharmaceutical CGMP violations. The firm manually filled multiple drug products from bulk liquid using a small flow hood on an office desk. FDA observed that the hood was neither certified nor qualified and was located in unclassified office space without HEPA filtration. FDA stated that these conditions lacked appropriate facilities, equipment, and process controls to protect products from microbiological contamination. FDA also found no quality unit function or written procedures defining its responsibilities. Basic procedures were absent, including complaint review, supplier qualification, release testing, change management, cleaning, disinfection, and deviation handling. FDA further reported missing batch numbers for sterile ophthalmic products manufactured since 2024, impairing traceability. The firm committed to cease U.S. manufacturing and distribution of PReye Vitamin SEE; it later voluntarily recalled the product because sterility testing had not been performed.

FDA Warning Letter: Insanitary API Manufacturing, Incomplete Laboratory Data, and Weak Quality Oversight

by

FDA states that its April 13 to 17, 2026 inspection of Shoolin Pharma Chem LLP found APIs prepared, packed, or held under insanitary conditions and identified significant API CGMP violations. Investigators observed layered unidentified residues, chemical residues and stains on walls, floors, equipment, and product-contact areas; corroded or apparently rusted surfaces; leaking lines; improperly stored transfer lines; and an employee wearing open-toed sandals near open equipment during production. Nondedicated equipment was used for multiple APIs. FDA also found inadequate written cleaning and maintenance procedures, no swab or rinse cleaning verification, and insufficient cleaning validation remediation. The firm could not provide raw data supporting certificate-of-analysis results, while contract-laboratory results were reported on company letterhead without identifying the original laboratory. Stability chambers were powered off or outside temperature or humidity conditions, supporting records were unavailable, and tadalafil samples were missing. FDA further cited inadequate quality-unit oversight of impurity risks, contract laboratories, process validation, equipment calibration, materials testing, and annual product reviews. The firm recalled all APIs distributed in the U.S., and FDA placed its drugs on Import Alert 66-40.