Materials Management

FDA Cites Stream2Sea for OTC Drug Manufacturing CGMP Violations

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FDA issued a warning letter to Stream2Sea LLC after a July 2025 inspection identified significant CGMP violations in finished OTC drug manufacturing. FDA cited inadequate final-product chemical and microbiological testing before batch release, including release before documented quality-unit approval. The agency also found missing identity testing of incoming components, reliance on supplier certificates of analysis without establishing supplier test reliability, and no supplier qualification program. FDA further cited inadequate cleaning validation and records for shared, non-dedicated equipment used for OTC drugs and cosmetics. It requested independent assessments, remediation plans, specifications, procedures, retrospective evaluations, and a written response within 15 working days.

FDA Warns Bentley Laboratories Over CGMP, Testing, and Validation Failures

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FDA issued a warning letter to Bentley Laboratories following a March 2026 inspection, citing significant CGMP violations for finished pharmaceuticals. FDA found inadequate investigations of out-of-specification stability and cleaning results, deficient root-cause analysis and CAPA, unjustified specification changes, and insufficient quality-unit oversight. The agency also cited inadequate incoming-component identity and impurity testing, reliance on supplier certificates of analysis without establishing reliability, and weaknesses in supplier qualification. Manufacturing and cleaning processes were not adequately validated or revalidated after changes, and validation protocols were not fully executed. FDA also determined that two acne products were unapproved new drugs and misbranded, and acknowledged the firm’s commitment to suspend certain OTC drug production.

FDA Warns Kellin Chemicals Over Refused API Facility Inspection

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FDA issued a warning letter to Kellin Chemicals (Zhangjiagang) Co., Ltd., an establishment registered as an active pharmaceutical ingredient supplier to finished-drug manufacturers serving the U.S. market. The firm’s U.S. agent told FDA that the company refused a preannounced inspection planned for July 7–11, 2025. FDA states that drugs made, processed, packed, or held there are adulterated under section 501(j) because inspection was refused. FDA may withhold application or supplement approvals listing the facility and may detain or refuse relevant U.S. shipments. The company was asked to respond within 15 working days and could request an inspection.

PIC/S Revises GMP Guide Annex 19 on Reference and Retention Samples

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PIC/S revised its GMP Guide for Medicinal Products to version PE 009-18, incorporating the revised Annex 19 on reference and retention samples. The revision primarily concerns Section 9, addressing samples for parallel imported, parallel distributed, and parallel traded products. A note specifying that Section 9 applies only where these activities are covered by local legislation has been retained. The PIC/S Committee adopted the revision by written procedure on 22 September 2026. PE 009-18 enters into force on 24 September 2026, coinciding with the revised EU Annex 19. Non-EEA PIC/S Participating Authorities and Applicants have been invited to transpose Annex 19 into their GMP Guides.

FDA Human Drug Compounding Information and Oversight Resources

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FDA describes human drug compounding as the combining, mixing or altering of drug ingredients by specified licensed professionals, or supervised personnel at an outsourcing facility, to create medication tailored to an individual patient’s needs. It states that compounded drugs are not FDA-approved and are not reviewed by the agency for safety, effectiveness or quality before marketing. FDA says its compounding program seeks to protect patients from poor-quality compounded drugs while preserving access to lawfully marketed products for patients with medical need. The page provides links on laws, policies, risk alerts, bulk drug substances, outsourcing facilities, registrations, inspections, recalls, state information and the Compounding Quality Center of Excellence.

Centric Compounding Recalls Six Injectable Lots for Elevated Endotoxin

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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

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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: Spa De Soleil cited for water system, component testing, validation, and quality unit deficiencies

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FDA inspected Spa De Soleil’s Sun Valley drug manufacturing facility in January 2026 and found significant CGMP violations affecting OTC topical drug production. FDA states the firm inadequately investigated 51 water-system microbiological OOL and chemical OOS results recorded from May 2024 through July 2025, including gram-negative recoveries, conductivity failures, and total organic carbon failures. Investigations relied on resampling and retesting without identifying microorganisms or adequately evaluating affected products. The water system contained dead legs, threaded fittings, Teflon tape, and ball valves, and monitoring did not reflect production schedules. FDA also found inadequate identity and impurity testing of incoming high-risk components, including controls for methanol, DEG, and EG, plus unverified reliance on supplier certificates of analysis. Manufacturing processes lacked adequate validation, and batch records omitted critical processing parameters and equipment identification. An alternative microbiological method was not shown equivalent to or better than USP methods. FDA further cited ineffective quality-unit oversight, insufficient contract-laboratory qualification, absent annual product quality evaluations, and unvalidated cleaning procedures. The February 2026 response lacked supporting documentation and adequate corrective-action evidence; similar violations had been cited in 2021.