FDA Inspection 573151 — P&L Developments, LLC
The FDA completed an inspection of P&L Developments, LLC on Mar 27, 2009 in Lynwood, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 27, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lynwood, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1768 | 21 CFR 211.137(b) | Storage conditions |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4356 | 21 CFR 211.166(b) | Tentative expiration date |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |
| 4576 | 21 CFR 211.192 | No written record of investigation |