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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Abbreviated Analytical Reporting

Subject:
Abbreviated Analytical Reporting
Area:
Operations Management
Date Revised:
September, 6 1994

 

 

PURPOSE

To simplify analytical reporting for survey samples which are collected for information purposes and which by nature of the collection and analysis are not used in compliance actions.

BACKGROUND

The Laboratory Procedures Manual (LPM), Chapter 12, section 1 2.5-Analyst Worksheets, gives basic instructions for reporting analyses on the Analyst Worksheet (FD-431). LPM, chapter 3, gives instructions for preparing the laboratory conclusion on the Sample Summary Report (F-465), which is required for all domestic regulatory samples.

Abbreviated reporting will be permitted for nonregulatory survey samples to promote more efficient use of laboratory resources. Full F-431 write-up and F-465 preparation are not needed.

Some compliance programs direct surveys to be conducted specifically for information gathering. By design these survey samples are precluded from being used in any regulatory action for a specific sample, (e.g., no 702 (b) portion, insufficient units analyzed, multiple manufacturers under one sample number, etc.). Generally, any follow-up to out-of-limits samples would be reported under a different compliance program or assignment, and not covered by this FMD.

SURVEY SAMPLES COVERED BY THIS FMD

This FMD covers nonregulatory survey samples. The compliance program or assignment should specify that the sample is collected for information gathering purposes ONLY. It will not be used for or in support of a regulatory action.

This does not include reporting for follow-up to out-of-limits survey samples.

GENERAL INSTRUCTIONS

All information required by the survey must be furnished to the Center or parties initiating the survey, in the format specified in the compliance program or assignment.

When a reporting form is included in the assignment, i.e. as an attachment, the required information should be submitted to the appropriate parties. If specific instructions are given for completing the F-431 (analyst worksheet), these should be followed.

The use of abbreviated reporting is optional and must be approved by the laboratory director. A copy of the specific worksheet or protocol and justification of its use must be included in the laboratory's SOP. Guidance for abbreviating the report is furnished below.

Abbreviated worksheets may take many different formats depending upon specific district utilization; however, basic minimum criteria must be met. For No Action Indicated (NAI), the document must show the sample number, product name, analytical method reference(s), analytical findings, and supervisory approval.

Any deficiencies observed by the analyst with respect to container, labeling, package or container code, and product are to be described for the pertinent sub(s) on the front of the F-431.

Note: In some districts the abbreviated worksheet may be a computer generated worksheet meeting the above requirements and/or may also be placed on electronic media, such as computer diskettes for collection and transmittal to the respective Centers, DFS and other appropriate parties.

ANALYST WORKSHEET

1. Item 7 Description of Sample: Check what has been received against the C/R. Condense description to statement confirming that sample was officially sealed and subs listed in C/R are present (e.g., "Officially sealed. Contains subs described in C/R."). If sample is one that should have been received frozen or iced, state condition on receipt. Describe condition of ice control.

2. Item 8 Net Contents: Leave blank.

3. Item 9 Labeling: Check as appropriate. Submit number of labels required by the program.

4. Item 10 Summary of Analysis: Do not describe container, labeling or product, unless required by the program, or if deficiencies are found. Follow program directions for what and where to report and do not repeat information; e.g., package or container codes should not be described unless analysis is on the basis of these codes.

Give method and modifications used.

Summarize results only in program format. If program does not require a summary (e.g., certain microbiological programs require a F-431d to be submitted) do not summarize.

5. Item 11 Reserve Sample: Describe reserve required to be retained by the program per Laboratory Procedures Manual Chapter 12. If not required by the program, describe briefly and generally what remains.

6. Back of Worksheet: Record raw data per Laboratory Procedures Manual Chapter 12, except:

(a) Submit computer printout as continuation sheet when available. Do not recap the data on the back of the F-431. Identify each computer printout with page number, sample number, date and analyst's initials; explain entries that are not self-explanatory.

(b) Mount and identify other forms of printouts (e.g., chromatograms) and attach to the worksheet. Explanations may be necessary on the back of the worksheet.

PODS Reporting and Sample Summary

A sample classification is necessary so that analytical information can be entered into PODS. Survey samples as defined by this FMD will be coded "4" on the LMS coding sheet (F-2196) per Classification/Conclusion section of the FDA Data Codes Manual.

In lieu of completing an F-465 (Sample Summary), the reviewing officer may enter the appropriate data on the front of the worksheet through the use, perhaps, of a rubber stamp. This data should show sample classification "4", date, supervisor's name, and "SDN issued", if the SDN is issued immediately after supervisory review.