FDA Inspection 797889 — M FATEH & K SULTAN M D S P C
The FDA completed an inspection of M FATEH & K SULTAN M D S P C on September 5, 2012 in New York, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 5, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12249 | 21 CFR 1271.55(d)(3) | Records not made available to FDA |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12281 | 21 CFR 1271.75(c) | Reproductive cells/tissues-Chlamydia, Neisseria |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12290 | 21 CFR 1271.80(d)(1) | Reactive tests--not determined ineligible |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |