FDA Inspection 711505 — Shair Laboratories, Inc.
The FDA completed an inspection of Shair Laboratories, Inc. on March 22, 2011 in Louisville, KY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 27 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 22, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Louisville, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1168 | 21 CFR 211.34 | Consultant Records |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1498 | 21 CFR 211.122(b) | Labeling and packaging improperly approved/released |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1724 | 21 CFR 211.134(b) | Representative samples after completion |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1774 | 21 CFR 211.142(a) | Quarantine - actual practice |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 3562 | 21 CFR 211.56(c) | Written procedures lacking for use of pesticides etc. |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4359 | 21 CFR 211.170(b)(1) | Retention time of reserve samples, in general |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |