FDA Inspection 546244 — M W Laboratories Inc
The FDA completed an inspection of M W Laboratories Inc on Nov 4, 2008 in Savannah, GA. 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). 25 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 4, 2008
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Savannah, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3562 | 21 CFR 211.56(c) | Written procedures lacking for use of pesticides etc. |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |
| 4371 | 21 CFR 211.188(b)(9) | Description of containers and closures |
| 4377 | 21 CFR 211.188(b)(3) | Identification of each component or in-process material |
| 4378 | 21 CFR 211.188(b)(2) | Identity of major equipment and lines used |