FDA Inspection 815531 — Mid-Continent Packaging, Inc
The FDA completed an inspection of Mid-Continent Packaging, Inc on Jan 24, 2013 in Enid, OK. 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). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 24, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Enid, OK (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4359 | 21 CFR 211.170(b)(1) | Retention time of reserve samples, in general |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |