# FDA WARNING_LETTER - Safecor Health, LLC - March 16, 2023

Source: https://www.keypedia.com/records/warning_letter/safecor-health-llc/8521ff6d-bf16-4bb3-ae52-3f065864a452

> FDA WARNING_LETTER for Safecor Health, LLC on March 16, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Safecor Health, LLC
- Inspection Date: 2023-03-16
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations I
- Summary: The FDA inspected Safecor Health LLC's drug manufacturing facility in Woburn, MA, from March 7-16, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include:
1.  **Inadequate Packaging and Labeling Facility Inspection (21 CFR 211.130(e)):** The firm failed to ensure complete line clearance, evidenced by various capsules and tablets found on/under the blister packaging machine during an aspirin run. This increases mix-up risk, supported by a history of product mix-up complaints and recalls (e.g., tacrolimus containing a vitamin, mislabeled enoxaparin). The firm's response of retraining and an additional verification step was deemed insufficient due to lack of detailed batch records.
2.  **Failure to Establish Adequate Cleaning and Maintenance Procedures (21 CFR 211.67(b)):** Unidentified white powder residue was observed on "clean" equipment surfaces. The 2019 cleaning requalification lacked scientific rationale for "random selection." The firm's response to store cleaned equipment in an enclosed cabinet and add a pre-use cleaning step was inadequate as the residue was not identified, and cleaning procedure adequacy was not addressed.
3.  **Failure to Test Components (21 CFR 211.84(d)(2)):** The

## Related Documents

- [483 - 2016-06-30](https://www.keypedia.com/records/483/safecor-health-llc/cd99bf24-180f-48d6-8c0c-2473de151284)
- [EIR - 2018-02-02](https://www.keypedia.com/records/eir/safecor-health-llc/68fe04cb-494f-497e-a1e3-ded7842780ef)
- [483 - 2018-02-02](https://www.keypedia.com/records/483/safecor-health-llc/b5c66512-b5a2-471f-acc9-d77049bd052b)
- [483 - 2023-09-01](https://www.keypedia.com/records/483/safecor-health-llc/3a126c11-9649-4f0a-9284-c31cdbe70fda)

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/lisa-m-harlan/e5d04349-6dd6-4f08-b31f-bf719c8413ab)

Company: https://www.keypedia.com/companies/safecor-health-llc/0d429e90-aad6-4d51-bff3-4a4995282dae

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-i/6ded4818-ee3a-46a1-84c1-36de58502b02