Greene Respiratory Services, Inc
Form 483 issued March 31, 2023 · Columbus, Ohio
- Observations
- 11
- Pages
- 7
- FEI number
- 3025301785
In short: On March 31, 2023, FDA issued a Form 483 with 11 observations to Greene Respiratory Services, Inc in Columbus, Ohio (FEI 3025301785). Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and production account for 8 of 11 observations.
Most cited: 21 CFR 211.22 (3×) · 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no quality…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Employees are not given training in…
- 04
Procedures describing the handling of written and oral complaints related to drug products are…
This inspection in context
Questions about this 483
What did FDA find at Greene Respiratory Services, Inc?
FDA listed 11 observations on this Form 483, mostly about quality system, production and packaging & labeling. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
When was Greene Respiratory Services, Inc inspected by FDA?
This Form 483 is dated March 31, 2023.
How do I get the full Form 483 for Greene Respiratory Services, 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.