FDA Inspection 590126 — Bryant Ranch PrePack
The FDA completed an inspection of Bryant Ranch PrePack on June 11, 2009 in Burbank, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 11, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Burbank, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 3551 | 21 CFR 211.46(d) | Penicillin air handling systems not kept separate |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |