In 2021 again Numerous FDA 483s due to Deficiencies in the Stability Program

Observations made by the inspector during an FDA inspection are listed on the FDA Form 483. Spreadsheets summarizing the areas of regulation cited on FDA's system-generated 483s are available by fiscal year on the FDA's homepage in the subsection on "Inspection Observations". These spreadsheets represent the area of regulation and the number of times it was cited as an observation on a Form FDA 483.

As you could read in "Numerous FDA 483s due to deficiencies in the stability programme", in the fiscal years 2019 and 2020, in the area of "Drugs" deficiencies in the stability program were mentioned in numerous FDA 483s.

The FDA has now published the data for the fiscal year 2021 (October 2020 to September 2021). 215 FDA 483s were issued in the area of "Drugs".

The following table gives an overview of typical deficiencies related to stability testing:

Rerence Number Short Description Frequency (fiscal year 2019) Frequency (fiscal year 2020) Frequency (fiscal year 2021)
21 CFR 211.166(a) Lack of written stability program 67 18 15
21 CFR 211.166(a) Written program not followed 29 13 12
21 CFR 211.166(a) Results not used for expiration dates, storage cond. 10 4 2
21 CFR 211.166(a)(1) Sample size - test intervals 4 1 0
21 CFR 211.166(a)(2) Stability sample storage conditions described 3 1 2
21 CFR 211.166(a)(3) Valid stability test methods 22 5 5
21 CFR 211.166(a)(4) Testing in same container - closure system 0 0 1
21 CFR 211.166(b) Adequate number of batches on stability 8 1 4
21 CFR 211.166(b) Accelerated stability studies 0 1 0
21 CFR 211.166(b) Tentative expiration date 1 1 0
21 CFR 211.166(c)(1) Homeopathic drugs, assessment of stability 3 2 1

Looking at the ratio of 483s in stability relative to the total number of 483s in the area of Drugs, the percentage in fiscal year 2021 is at the same level as in 2019:

Fiscal year 2019 Fiscal year 2020 Fiscal year 2021
FDA 483 forms in total (Drugs)


349 215
FDA 483 in the area of stability 147 47 42
Percentage 19% 13% 20%

The total number of 483s in 2021, against the background of the Corona pandemic and the associated backlog of inspections, is at a very low level compared to recent years.

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