MFCI (Huanggang) Co., Ltd.
Form 483 issued August 17, 2017 · Huanggang, China
- Inspection
- Aug 14 – Aug 17, 2017
- Observations
- 23
- Pages
- 8
- FEI number
- 3009773851
In short: On August 17, 2017, FDA issued a Form 483 with 23 observations to MFCI (Huanggang) Co., Ltd. in Huanggang, Hubei (FEI 3009773851) after an inspection that ran Aug 14 – Aug 17, 2017. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and laboratory controls account for 16 of 23 observations.
Most cited: 21 CFR 211.67 (5×) · 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records do not include a complete record of all data secured in the course of…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in quality…
- 03
The GC-based methods used for the determination of assay and impurities during stability studies of the…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Questions about this 483
What did FDA find at MFCI (Huanggang) Co., Ltd.?
FDA listed 23 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
When was MFCI (Huanggang) Co., Ltd. inspected by FDA?
The inspection ran Aug 14 – Aug 17, 2017, and the Form 483 is dated August 17, 2017.
How do I get the full Form 483 for MFCI (Huanggang) Co., Ltd.?
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.