OHM PHARMA INC.
Form 483 issued May 23, 2019 · Mineral Wells, Texas
- Observations
- 6
- Pages
- 7
- FEI number
- 3003231743
In short: On May 23, 2019, FDA issued a Form 483 with 6 observations to OHM PHARMA INC. in Mineral Wells, Texas (FEI 3003231743). Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Facilities & equipment and laboratory controls account for 4 of 6 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Records of the calibration checks or inspections of automatic, mechanical or electronic equipment , including computers…
- 03
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 04
Deviations from written test procedures or laboratory control mechanisms are…
This inspection in context
Questions about this 483
What did FDA find at OHM PHARMA INC.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was OHM PHARMA INC. inspected by FDA?
This Form 483 is dated May 23, 2019.
How do I get the full Form 483 for OHM PHARMA INC.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.