# FDA WARNING_LETTER - Whitney Labs - March 17, 2008

Source: https://www.keypedia.com/records/warning_letter/whitney-labs/25f9ee60-3af7-4caa-9c02-b908d2814379

> FDA WARNING_LETTER for Whitney Labs on March 17, 2008. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Whitney Labs
- Inspection Date: 2008-03-17
- Product Type: Drugs
- Office Name: Florida District Office
- Summary: On March 12-17, 2008, the FDA inspected Whitney Labs, a prescription drug repackaging and relabeling facility, finding significant CGMP deviations (21 CFR Parts 210 and 211), rendering products, including Methadone HCl, adulterated. The inspection also revealed misbranding of [(b)(4)] unit-doses of 260mg/26mL liquid Methadone HCl mislabeled as 20mg/2mL, with [(b)(4)] distributed.

Key violations include:
1.  **Lack of a Quality Control Unit:** No designated unit with authority to approve/reject materials, review production records, or approve procedures (21 CFR § 211.22).
2.  **Inadequate Production/Process Control Procedures:** Automated packaging line and software systems were not validated (21 CFR § 211.100(a)).
3.  **Failure to Follow Procedures:** Employees did not follow label changeover or equipment verification procedures, leading to the Methadone mislabeling (21 CFR § 211.100(b)).
4.  **Insufficient Investigations:** Mislabeling, leaking containers, and missing labels were not thoroughly investigated for root causes (21 CFR § 211.192).
5.  **Lack of Component/Container Procedures:** No written procedures for testing

## Related Officers

- [District Director](https://www.keypedia.com/people/emma-r-singleton/e0b72aba-caa5-4cf8-8beb-6f93f6654e59)

Company: https://www.keypedia.com/companies/whitney-labs/4b9391a1-4de1-4154-8916-152a6bda94bb

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9