Whitney Labs – FDA Warning Letter, Mar 17, 2008

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